A draft Withdrawal Agreement between the EU and the U.K. has been published by the European Commission (28/02/2018), which puts the agreement on Phase 1 of Brexit negotiations reached in December into a legal document.

In this agreement, the U.K. is required to “make available without delay” the marketing authorisation application of a drug approved by the U.K. competent authorities before the end of the Brexit transition period, if an EU Member State or the European Medicines Agency requires it.

U.K. notified bodies should also provide information to other EU countries about their certification activities until the end of the transition period, should a certificate holder require it (e.g. a medical device manufacturer). Notified bodies in the EU are also required to do the same for the U.K.

The agreement also says that EU rules would still apply if a new application for a supplementary protection certificate (for drugmakers and pesticide manufacturers) or for an extension was made before December 31, 2020 – the end of the transitioning period.

The agreement also says that the U.K. will lose access to any EU network, database and information system after the transition period. This is expected to include the EU Early Warning and Response System which monitors public health threats and also the Rapid Alert System for Food and Feed which sends alerts about potential threats detected in the food supply. This may also affect access to EudraVigilance, the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area.

For further information please contact Julia Gillert of our London office or Els Janssens of our Abu Dhabi office.

Ireland’s EU commissioner has said that Theresa May needs to drop her Brexit red line on the customs union to break the impasse on the Irish border question. Phil Hogan said there was deep frustration in Brussels that with just seven months to the deal deadline, the conversations were still “London-London and not London-Brussels”. He said May had painted herself into a corner by starting her negotiations with so many red lines and if the UK did not want to crash out of Europe it needed to review them. He suggested that May’s opposition to a “backstop” option where Northern Ireland would be in regulatory alignment with the EU contradicted the UK’s position in previous talks. (The Guardian)

The UK government is expected to mount an immediate legal challenge at the supreme court if the Scottish parliament votes for its own emergency powers over Brexit. Legal and political sources have told the Guardian it is highly likely that Richard Keen QC, the UK government’s Scottish law officer, would ask the supreme court to strike the legislation down, plunging both governments into a long-running legal and constitutional battle with ramifications for the Scottish independence debate. A legal source said the attorney general, Jeremy Wright QC, was almost certain to challenge equivalent legislation being considered by the Welsh assembly in the supreme court, if it too voted those powers into law.(The Guardian)

Donald Tusk has said Theresa May needs to come up with “a better idea” than the EU’s controversial plan to prevent a hard border in Northern Ireland. The PM has rejected keeping Northern Ireland in the EU’s customs area saying this would split the UK in two. But the European Council president said one of the “possible negative consequences” of the kind of Brexit Mrs May wants would be a hard border. The two met in No 10 ahead of a big Brexit speech on Friday by Mrs May.(BBC)

Mrs May, who chaired a meeting of the cabinet before her talks with Mr Tusk, has already pledged not to accept the draft withdrawal treaty published on Wednesday by the EU. The UK car industry would be “hugely” damaged — with inward investments threatened and thousands of jobs put at risk — should Britain crash out of the EU without a trade deal, MPs said in a report published on Thursday. A report by the Commons business, energy and industrial strategy select committee into the impact of Brexit on Britain’s automotive sector said that negotiations with the EU were merely “damage limitation” to prevent vehicle production moving overseas. (Financial Times)

Prime Minister Theresa May is facing divisions in her Cabinet on how far she should aim to keep the U.K. in line with European Union rules as she prepares to reveal her latest thinking on Brexit. The problem is that even after a two-hour meeting where many top ministers said they were broadly happy, the key question of how close — or far — to be to the bloc remains unanswered, according to people familiar with the matter. Some pro-EU ministers like Greg Clark want her to make a binding commitment to align Britain’s rules and regulations in key industry sectors with those of the European single market. Others, including Brexit Secretary David Davis and Foreign Secretary Boris Johnson pushed back against this idea. (Bloomberg)

Theresa May said that no UK prime minister could “ever” accept new EU proposals that could keep Northern Ireland under the bloc’s rules, as she hit out at Brussels’ first draft of a Brexit treaty. Speaking after the commission released a 120-page draft withdrawal text, the prime minister said the contingency plans for Northern Ireland would, if implemented, undermine Britain’s common market and “threaten its constitutional integrity” by creating a customs and regulatory border between the province and the rest of the UK. “No UK prime minister could ever agree to it,” she told the House of Commons, adding that she would make her refusal “crystal clear” to Jean-Claude Juncker, the European Commission president. (Financial Times)

Theresa May has conceded that new EU migrants who come to Britain during the Brexit transition will have the right to settle permanently in the UK, in a major climbdown over future residency rights. The concession, slipped out in a Brexit policy paper by the Home Office, also makes clear that new EU migrants who arrive after March 2019 will be given a five-year temporary residence permit, not the two-year one that was previously proposed by ministers. The policy paper does, however, make clear that new EU migrants who come to live and work in Britain after the transition period gets under way will not have the same rights after the Brexit transition to bring family to join them as EU nationals already resident in Britain who have secured “settled status”. Instead, they will have to pass a minimum income threshold test, which is currently set at £18,600 for British and settled residents but not EU citizens. (The Guardian)

The ex-prime minister argues that MPs must vote with their “own conscience” on whether the deal on offer will leave the UK better or worse off. And, in a speech in London, he said they could decide on a new referendum. Leading Tory backbencher and Brexit backer, Jacob Rees-Mogg, said Sir John had been wrong on Europe in the past “and he is getting it wrong again”. “We had a democratic vote, the decision has been taken and what he is trying to do is overturn that,” he told BBC News. Speaking to the BBC’s political editor Laura Kuenssberg, Sir John insisted he was not “targeting” Theresa May and he genuinely wished her well in getting the best deal for Britain.(BBC)

The European Commission’s draft withdrawal agreement for Brexit was published a few hours ago. The intended deal will address only the arrangements for withdrawal, including transition. The future trade, security and other relationships between the EU and the UK will be the subject of other intended agreements. It is too soon for anyone to have digested all the detail of the document, and indeed it may be weeks before some of the implications of the provisions become clear. That is the nature of complex legal instruments. But, at this stage, there are some observations to be made about the draft itself and how it may affect the wider process of the intended departure of Britain from the EU. The first thing to say is that it is a welcome development that there is a draft in existence. We are almost one year on from the Article 50 notification and nearly two years on from the referendum. Much of the discussion on Brexit has been in general, even strident terms. Now there is something more substantial to focus on, and to argue about. (Financial Times)

The EU’s negotiator Michel Barnier has re-emphasised that significant differences remain between the UK and EU over the length of any post-Brexit transition period. He suggested the UK wanted an “open-ended” arrangement while the EU wanted a “short and time-limited” period that would last no more than 21 months. He said he hoped the publication of a draft withdrawal agreement on Wednesday would help address unresolved issues. (The BBC)

Foreign secretary Boris Johnson has twice in one day been caught up in the sensitive issue of the Northern Ireland border after Brexit. In a radio interview on Tuesday, he compared the border issue in Ireland to crossing between London boroughs. And later in the day a leaked letter from the leading Brexiter played down the significance of an issue that seems set to play an important part in the next stage of negotiations. (The Financial Times)

Northern Ireland may be considered part of the European Union customs territory post-Brexit, Irish national broadcaster RTE is reporting, as part of the draft legal text to be published by the European Commission on Wednesday. The text will allude to a single regulatory space on the island of Ireland with no internal barriers, adds the broadcaster. The report cites “a well-placed EU source”. (The BBC)

The Scottish and Welsh administrations on Tuesday raised the stakes in the constitutional dispute with the UK government over Brexit by unveiling emergency legislation that would try to ensure that powers currently exercised by Brussels are transferred to Edinburgh and Cardiff. The devolved administrations have accused the UK government of wrongly seeking to use Britain’s departure from the EU to engage in a power grab – notably in relating to farming and fishing. (The Financial Times)

The EU will demand this week that the UK remains subject to European Court rulings indefinitely under its Brexit divorce deal, forcing Theresa May into another fraught battle over the writ of Luxembourg judges. Brussels will propose that the UK is required to accept the European Court of Justice as the ultimate arbiter to treaty-related disputes, according to three officials who have seen the text. (The Financial Times)